普卢利沙星治疗急性尿路感染的随机双盲对照试验

目的评价普卢利沙星治疗急性尿路感染的有效性和安全性。方法根据本研究的纳入和排除标准,选取急性尿路感染患者144例,按计算机随机表产生的随机号将患者分为两组,进行随机双盲、双模拟对照试验。试验组服用普卢利沙星200mgbid;对照组服用左氧氟沙星200mgbid。疗程均为5～10天。结果两组各有67和61例可进入全分析集(FAS),各有63和59例可进行符合方案集(PP)分析。FAS分析结果显示,试验组和对照组的临床有效率分别为85.07%和88.52%;细菌阴转率试验组为93.75%,对照组为93.88%。PP分析结果显示,试验组和对照组的有效率分别为90.48%和91.53%;细菌阴转率分别为97.83%和97.87%。两组临床疗效和细菌学疗效阴转率差异均无统计学意义(P>0.05)。普卢利沙星和左氧氟沙星的不良反应发生率分别为2.8%和5.6%。结论普卢利沙星对敏感菌引起的尿路感染疗效确切,安全性好。

Prulifloxacin in the Treatment of Urinary Tract Infection: A Double-Blind, Randomized Controlled Trial

Objective To assess the effectiveness and safety of prulifloxacin in the treatment of urinary tract infection. Methods The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group (prulifloxacin , 4 tablets, bid) and the control group (levofloxacin, 4 tablets, bid). The randomization code was produced by computer. The treatment duration for both groups was from 7 to 10 days. Results Data were analyzed on the basis of full analysis sets (FAS) and per-protocol (PP) analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates (P>0.05). Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates (P>0.05). The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively. Conclusion Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.